The invention pertains to implantable medical devices and, in particular, to a self-expanding prosthetic device for sustaining a vessel or hollow organ lumen.
Various diseases of blood vessels or hollow organs cause a stenosis or complete obturation (occlusion) of their lumen, which results in a decrease or complete loss of their functional attributes. The wide spread of diseases of this kind demands an elaboration of quite new methods of medical treatment.
Devices for sustaining a blood vessel or hollow organ lumen typically have a tubular shaped frame body which is introduced in the vessel or hollow organ and fixed in the necessary place to sustain its lumen. The problem of designing such devices has already a twenty year history. Nevertheless, a universally reliable device satisfying all necessary requirements has as yet not been created.
A device for sustaining a vessel or hollow organ lumen should satisfy the following requirements:
effectively fulfill the function of recovering and sustaining the vessel or hollow organ lumen;
have a reliable and simple delivery control system;
have a wide range of sizes from 3 to 50 mm and more;
have biological compatibility with organism tissues;
be useable in different anatomical areas of vessels and hollow organs;
cause minimum trauma during and after operation; and
have a stiff construction to counteract in situ external compression forces.
An attempt to create a device compatible with tissues was undertaken in USSR Patent No. 1237201, dated Feb. 15, 1986. This known device for sustaining the vessel or hollow organ lumen represents a wire frame having a tubular shaped body. The frame is formed by a wire element, having round or square cross-section and arranged in a cylindrical helical line. The frame has a shape of a helical cylindrical spring and it is furnished with fixing elements to keep it on the device for delivery into the vessel or hollow organ. Each fixing element is made in the form of a loop, one of which is formed at the initial section of the wire element, and the other at its final section. The facility for delivering the above device to a vessel or hollow organ comprises an introducer in the form of an X-ray contrast tube and another X-ray contrast tube of a lesser diameter, on whose surface the device is secured by means of a connecting element. The material of the frame wire is an alloy of the titanium-nickel system, which is biologically compatible with the organism tissues.
The device known from the USSR patent is reliable in use. However, it is expedient to use the known device in vessels or hollow organs having a diameter of not more than 8 mm, which is conditioned by the value of the ultimate strain of the frame material limited by 8% (the so-called strain limit of shape memory effect), as well as by the demand of minimizing the puncture hole (hole in vessel through which the device is introduced into an organ). Furthermore, the device can withstand only limited external compression forces.
The use of the known device in vessels and hollow organs with a diameter exceeding 8 mm, and without exceeding the ultimate strain of the frame material, would demand a decrease of the thickness of the wire frame elements, which would result in a further loss of stiffness of the frame. Alternatively, it would be necessary to increase the diameter of the puncture hole, which in turn would cause intolerable trauma to the vascular or hollow organ walls. Thus, the mentioned construction of the device for sustaining a vessel or hollow organ lumen is applicable only for vessels or hollow organs whose diameter is less than 8 mm, which sharply narrows the field of its application.
The execution of the function of effectively recovering and sustaining a vessel or hollow organ lumen by the described device demands an arrangement of the coils of the wire frame with a minimum lead to prevent germination of atherosclerotic patches, or counteract the occlusion. However, the making of the frame with a minimum lead between coils results in a loss of its stiffness in the vessel or hollow organ. As a result, external compression forces effect a change of the frame""s arrangement in the vessel, i.e., the frame""s longitudinal axis gets arranged at an angle to the vessel axis, or in an increase of the lead between coils. Both in the first and second cases, the frame stops functioning, and the vessel or hollow organ lumen gets reduced.
As it was described above, the frame is furnished with fixing elements on the front and rear ends. The fixing elements are made in the form of loops lying in the plane perpendicular to the frame axis in such a manner that the partial overlapping of the frame lumen occurs. As a result, turbulent flows in the blood current are formed and facilitate the appearance of various complications such as atherosclerotic formations.
The described facility of frame delivery is reliable enough in the process of introduction of the frame to the affected area. However, at installation of the frame with the aid of this facility one of the fixing loops gets released. The frame, being scragged up until this moment, gets released and uncoils in the direction opposite to the direction of coiling at its fixing, acquiring its initial shape. In the process of uncoiling, which is uncontrolled, trauma to the vascular or hollow organ walls may occur, which has an unfavorable affect on the result of operation. In addition, the frame can occupy an arbitrary position in the vessel that is uncontrolled by the surgeon.
The described frame has the shape of a helical cylindrical spring. If we examine the frame section in a plane perpendicular to the frame axis and passing through the coil surface, it is seen that the frame coil located in the plane has a break, which decreases the frame stiffness under the effect of radially acting forces.
Another device for sustaining a vessel or hollow organ lumen is known (Ann Radiol, 1988, 31, n.2, 100-103), and it has a tubular shaped wire frame formed by a wire element, which in development represents a saw-tooth line. In order to permit a change in the stiffness of the frame, the latter is bound at the tops by a caprone thread.
The branches of the wire element are arranged along the longitudinal axis of the tubular frame, which provides for a constancy of the frame""s linear dimensions at the delivery and installation of the frame in the affected place of the vessel or hollow organ. To fix the frame in the vascular or hollow organ walls, provision is made for fixing elements in the form of hooks.
In the described construction, use is made of materials whose ultimate elastic strain makes up tenths of a percent. The delivery system represents an X-ray contrast tube accommodating a pusher, which is a piston with a rod. For transportation (delivery), the device is placed in the X-ray contrast tube, and by means of the rod the surgeon acts upon the piston interacting with the device.
The described device has found a wide application for sustaining the lumen of the affected areas of veins, in which there are no atherosclerotic processes. The use of this device in arterial vessels is hardly possible because of the large distances between the wire elements, which may result in germination of atherosclerotic patches and, as a consequence, in an ineffective use of this device.
The latter known device is used for sustaining the lumen of the affected areas of veins whose diameter is within 15 to 30 mm. In this case, a wire of a large diameter is used to impart the necessary stiffness to the construction. If this device were to be used in smaller vessels or hollow organs having a diameter from 3 to 15 mm it would be necessary to decrease the wire thickness (diameter). However, the loss in diameter thickness may hardly provide an effective means for sustaining the lumen.
Due to the arrangement of the wire branches in the peripheral direction of the tubular frame body, the given construction is stable and has a high stiffness in the axial direction, which prevents full adjustment of the vessel geometry and may traumatize the vascular or hollow organ walls.
When it is necessary to deliver the above device to the affected area along a curved path, the elastic deformation of the frame wire elements changes into plastic deformation, which results in an irreversible change of the device shape. Thus, delivery of the given frame to the affected place is possible only along a path close to a straight line, which considerably narrows the number of the anatomical areas, where the frame could be used.
A device of the initially mentioned kind is known from EP-A-221570. In this device, the larger axis of each cell is arranged in the axial direction of the tubular body and the smaller axis in the circumferential direction thereof. The wire sections forming the cells are rigidly interconnected.
The delivery facility of the described device comprises an X-ray contrast tube with an inflatable balloon, on the outside of which the wire frame is located. To press the wire frame onto the X-ray contrast tube, provision is made for one more tube enveloping the frame on its external surface. In delivery of the frame to the affected area of the vessel or hollow organ, the external tube is removed, and the balloon is inflated so that the frame is expanded and acquires its final shape whereafter it interacts with the vascular walls. Then, the X-ray contrast tube is removed from the vessel, and the frame is installed in the affected area.
Its delivery and installation in the affected area is sufficiently reliable and convenient. However, the use of a rigid joint by fusing together, soldering or welding of the wire elements in the points of their intersection seems to be unreliable because of:
a probable proceeding of electrochemical processes in the soldering zone, which may cause damage to the joint, loss of stiffness in the frame and consequently, loss of its functional attributes; and
formation of the so-called welding zone with an embrittled material structure, which may make this joint unreliable.
The described device can be used for sustaining the lumen of vessels or hollow organs within a range of sizes from 3 to 8 mm. In the described construction use is made of materials whose ultimate elastic strain makes up tenths of a percent. When it is necessary to deliver the device to the affected area along a curved path, a danger arises to exceed the ultimate elastic strain and, consequently, the proceeding of the process of plastic deformation of the frame material. Thus, the delivery of the given frame is possible only along a path close to a straight line, which essentially decreases the possibility of its use in different anatomic areas. The known device has a large stiffness in the axial direction which may traumatize the walls of the vascular or hollow organ in the regions around the ends of the device if the device supports a vascular or hollow organ which changes its shape during adaptation to varying external loads. Further, it is a common disadvantage of the known devices that they possess limited radial stiffness, which allows them to support only vascular or hollow organs that are not surrounded by a bone structure taking up external loads.
The invention is based on the problem of creating a device for sustaining a vessel or hollow organ lumen, in which the shape and arrangement of cells forming the tubular frame provide the frame with a large stiffness in the radial direction and only low stiffness in the axial direction so that the device without risk of traumatization will keep the vascular or hollow organ open, even if the latter changes shape due to external loads.
This is obtained by a prosthetic device having a wire frame in the form of a flexible tubular shaped body which in development is formed by many rows of interconnected cells, each of which cells comprises two U-shaped wire sections forming together approximately an elongated oval with a larger axis and a smaller axis, wherein adjacent cells in neighboring rows are shifted by half of the larger axis of the oval with respect to each other in the direction of the larger axis and are shifted by the smaller axis of the oval with respect to each other in the direction of the smaller axis. According to the invention, the device is characterized in that the larger axis of the oval is directed in the circumferential direction of the tubular body and the smaller axis parallel to the axial direction thereof so that in a plane perpendicular to the longitudinal axis of the body one of the branches of the U-shaped wire sections in one row forms together a closed ring shape.
By arranging the cells so that the larger axis of the oval is directed in the circumferential direction the device has on one hand a large flexibility in the axial direction which allows the device to bend simultaneously with the vascular or hollow organ even if the bending is very localized because the long branches of the U-shape are easily deformed in the axial direction. In addition, the device is very rigid towards localized radial compression because the U-shaped branches of each row of cells form two circumferential rings having a relatively high stiffness in their plane. The flexibility of the device in the axial direction further ensures that a local deformation of the vessel does not cause the device to lengthen in the axial direction as the deformation is absorbed within the pressure affected rows of cells. This causes the device to stay fixed with respect to the surrounding supported wall of the vascular or hollow organ so that traumatization is avoided. Under the action of external compression force, the ring shape is essentially uniformly loaded. The axial stiffness of the device can to some extent be adjusted as needed by varying the cross-sectional area of the frame wire. By varying the number of cells in the frame, it becomes possible to select the optimum axial stiffness of the frame, so that the vascular or hollow organ wall is traumatized as little as possible.
In a preferred embodiment, adjacent cells in one row are interconnected in a flexible manner at the axially extending portion of the U-shaped wire sections. The flexible interconnection allows large deformations of the initially unloaded cell geometry without large deformations in the wire proper because the wire sections are not rigidly fixed to each other.
When the device is to be introduced, the ends of the tubular frame are pulled away from each other and the frame diameter is reduced until the frame can be inserted into a delivery catheter. During lengthening of the frame, the major portion of cell deformation occurs in the long branches of the wire sections, and it is assumed that the axially extending portion of the U-shaped wire sections is only slightly deformed so that the entire U-shaped wire section is substantially uniformly loaded. Consequently, the diameter of the tubular frame may be drastically reduced during insertion without exceeding the elastic strain limit of the wire material. This makes it possible to use devices according to the invention within a wide range of sizes and to introduce the devices through a small puncture hole in the patient, even if the wire is made of, e.g., stainless steel.
Preferably the flexible interconnections are accomplished by winding the axially extending portions around each other, more preferably so that the one wire portion is wound only one turn around the associated wire portion. During deformation of the U-shaped wire sections, the windings may move apart and/or open which reduces strain in the wire. The wound wire portions also act as a kind of hinge joint allowing the two U-shaped wire sections in a cell to swivel with respect to each other when the frame is radially loaded. The wound flexible interconnections present a further advantage, namely that as an alternative to axially lengthening of the frame prior to insertion in the catheter the tubular frame may be twisted about its longitudinal axis by turning the two frame ends in opposite directions. This causes the wound interconnections to open and the frame to collapse to a reduced diameter allowing insertion. When the frame after positioning abreast of the site to be supported is pushed out of the catheter it xe2x80x9cuncoilsxe2x80x9d to its initial diameter without any substantial axial shortening of the frame, which leads to an uncomplicated and very precise positioning of the device in the vascular or hollow organ.
In a further embodiment, which is preferred due to its simplicity of manufacture, the device is characterized in that each U-shaped wire section is composed of two separate wires each of which runs helically through the rows of cells, and that the two wires are wound, preferably, one turn around each other at the axially extending portion where they meet to form the bottom leg of the U-shape.
The device may have wires of a shape memory alloy exhibiting thermally activated shape memory properties, preferably a nickel-titanium alloy, but more preferably the wires are of a shape memory alloy exhibiting superelastic properties, advantageously a nickel-titanium alloy. Such a shape memory alloy can be excessively deformed and yet return to its set predetermined shape without loss of stiffness or introduction of permanent deformations in the wire. The shape memory alloy wire frame can be reduced to a diameter of only a few mm during insertion irrespective of its unloaded diameter which, e.g., may be as large as 50 mm so that the frame can be introduced into the patient through a single small diameter catheter requiring only a small puncture hole in the patient. The superelastic alloy is preferred in order to avoid thermal control during insertion. When this alloy is deformed it exhibits stress induced martensite.
The above-described possibilities of variation of the axial and radial stiffness of the frame allow the latter to fulfill the function of sustaining a vessel or hollow organ lumen within any range of their standard sizes, for example, from a diameter of 3 mm to a diameter of 50 mm, and be applicable in different anatomical areas of the vessel or hollow organ and even to be introduced along a tortuous path. The device may also be used for retention of blood clots as a Vena cava filter.
The aforementioned prosthetic device of the present invention has been described with the flexible interconnections all being wound in either a clockwise or counterclockwise direction. Although well suited for its intended purpose, the stent with its flexible interconnections all wound in the same direction exhibits a twisting, spiraling, corkscrewing, or uncoiling motion as it is deployed from the end of a delivery catheter or tube. This uncoiling motion was previously described and is undesirable in that plaque or other material formed on the wall of a vessel can be dislodged with undesirable trauma occurring to the patient. By way of example, this trauma could result in the formation of an embolism and resultant patient death. To minimize, if not eliminate this undesirable motion, the flexibly interconnected wire segments of the stent are selectively wound in opposite directions to effectively counterbalance the stent.
In one embodiment of the present invention, the flexibly interconnected wire segments of the cells in each row are all wound in the same direction, whereas the wire segments of the cells in an adjacent row are all wound in an opposite direction. This advantageously counterbalances the moments formed by the flexibly interconnected wire segments around and along an adjacent pair of rows. Furthermore, the winding of the wire segments in this manner forms a uniformly shaped wall with a minimum wall thickness.
In another embodiment of the present invention, the flexibly interconnected wire segments in each cell are wound in opposite directions to counterbalance the moments formed in the cell. As a result, the flexibly interconnected wire segments in each cell and row of the stent are advantageously counterbalanced. Adjacent loops at one end of the stent as well as fixedly secured, adjacent wire segments at an other end of the stent are also wound in opposite directions to further advantageously counterbalance the stent.